- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trained, following process and SOPs. The Director will ensure the Senior Director, Clinical Operations (Asset Lead ) is fully informed of the overall portfolio ... at the program level through the operational resources assigned to their program . May on occasion represent Global Clinical Operations on the Strategy and… more
- Eisai, Inc (Nutley, NJ)
- … Pharmacology will be relied upon to act independently, within a highly-matrixed clinical development organization and must have the experience and conviction to ... and programs according to established design principals and integrates them into the Clinical Development Plan (CDP) and Drug Development Plan (DDP)Leads… more
- Merck & Co. (Rahway, NJ)
- …Interacts closely with key partner organizations (as a lead GCS Planning program representative) such as clinical development , regulatory, quality and ... to GCS and serves as the lead GCS spokesperson at clinical and development related meetings.- Working independently, the Program CSPM designs strategic… more
- Eisai, Inc (Nutley, NJ)
- …members.Requirements Bachelor's or Master's degree with 15 or more years significant clinical pharmaceutical experience (ie, clinical development or ... and assess long-term resource, technology, and skill needs for respective program (s) within clinical quality area.Anticipate immediate and long-term risks… more
- Merck & Co. (Rahway, NJ)
- … Director at this level will be expected to lead a Product Development Team (PDT) through late-phase clinical development and into post-licensure ... journals. The Clinical Director will also contribute to establishing Vaccine Clinical Development Strategies and executing short- and long term research… more
- Merck & Co. (Rahway, NJ)
- …depth and breadth of scientific, technical, and operational experience to lead and support facility operations, process development activities, compliance ... Good Manufacturing Practices (GMP) facility within the Process Research and Development (PR&D) organization which enables gain of critical internal experience during… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …function by collaborating with internal and external stakeholders to oversee the development and delivery of clinical data programming, reporting, data ... validation, and reconciliation, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements that adhere… more
- Merck & Co. (Rahway, NJ)
- …is expected to be experienced in mammalian cell culture or purification process development , tech transfer of clinical or/and commercial processes, and pertinent ... talent development skills. Extensive experience as a drug substance lead for biologics pipeline programs. Strong capability in managing evolving timelines, … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(QRBs).Collaborate with business process owners to monitor the effectiveness of clinical development processes through KQIs, demonstrating process control and ... expertise in the involvement of regulated activities for medical affairs, or clinical development . requiredMust possess a solid understanding of global health… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of emerging data (internal or competitive), such as congress updates and development program highlights.- Provides medical leadership in interactions with key ... direction of the Senior Director, GMA Oncology ADC (Global Medical Affairs team lead for compound), is responsible for assisting with defining compound/ program … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pathology, to support design and implementation of translational pathology plans.- Lead development of the translational pathology strategic direction and ... statistical issues related to proposed business plans.- Communicate with portfolio leaders in Clinical Development , Discovery, QCP, CDx, RA, MA or other relevant… more
- Merck & Co. (Rahway, NJ)
- …the project as needed.-This includes the following activities:1. Is involved in late clinical development planning (LDP) to ensure that study designs are ... clinical trials and coordinating the statistical activities for clinical trial projects; and may lead a...software for planned analyses and ascertains needs for potential program development of novel statistical methodology.7. Analyzes… more
- Merck & Co. (Rahway, NJ)
- …execute, design verification strategies for assigned drug-device combination product program (s) for successful clinical introduction(s) and commercial market(s) ... plan, protocol(s), and report(s) that demonstrate design output(s) meet design input(s). Lead establishment of test methodologies, including method development … more
- Formation Bio (New York, NY)
- …than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number ... processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners,... and operational management of Formation Bio's quality assurance program to support the growing drug development … more
- Merck & Co. (Rahway, NJ)
- …Experience and Skills: Strong background in integrated analytical control strategy development and execution. Demonstrated ability to lead a technical ... collaborate to discover the next medical breakthrough.The Biologics Analytical Research & Development department of our Company's Research & Development Division… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …a manufacturing readiness strategy to deliver capacity ramp up to meet clinical and commercial demand.Drive capacity evaluations and lead action implementation ... information requests associated with executed capacity studies, as needed.Coordinates the development of operational models to meet clinical and commercial… more
- Bristol Myers Squibb (Madison, NJ)
- …in their personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Clinical Development Program Leader sits within Clinical ... and interpretation of clinical trials. + The Clinical Development Program Leader will...overall portfolio view + Provide strategic insights into the clinical development plans + Lead … more
- Organon & Co. (Jersey City, NJ)
- …Translational Medicine and Early Development (TMED) Department at Organon. The Clinical Pharmacology Lead also will be responsible for the rationale, study ... literature and regulatory guidance and support the approved early development plans. The Clinical Pharmacology Lead...optimizes dose selection, facilitates the efficiency of the overall program development plans and enables fastest to… more
- Sanofi Group (Morristown, NJ)
- …end planning, compliance and performance + Key role in advancing Sanofi's digital clinical development strategy + Contribute to Sanofi's commitment to accelerate ... **Job Title:** Clinical Operations Study Country Lead (COSCL)...the development of...eligible for a company car through the Company's FLEET program . Candidates must complete all fleet safety training and… more
- Regeneron Pharmaceuticals (Warren, NJ)
- …in one of our office locations. Fully remote is not eligible._ The **Senior Clinical Study Lead ** (CSL) is expected to operate with high-degree of independence ... for the global execution of assigned large and/or complex clinical trials from study design, through execution, to study...the assigned study + Provides operational input into protocol development + Oversees and provides input to the … more
